We will develop a rapid, specific, sensitive, and homogeneous detection system based on DNA amplification for the diagnosis of Chlamydia trachomatis infections in symptomatic as well as asymptomatic individuals. Chlamydia trachomatls is a major human pathogen responsible for a wide range of infections including Iymphogranuloma venereum, trachoma, inclusion conjunctivitis and genital tract infections. The rapid identification of chlamydia infections is, therefore, essential for the proper treatment of infected patients and for the prevention of transmission to susceptible individuals. Presently used tests for C. trachomatis are either too slow, not sufficiently sensitive, very laborious, or susceptible to cross contamination. A homogeneous system based on DNA amplification and concomitant detection (SEConD amplification system) has been developed in Biotronics Corps. In Phase 1, we will develop the amplification and detection primers for the SEConD amplification using the cloned C. trachomatis plasmid and genomic DNA sequences as targets. In Phase 11, we will adapt this assay for direct detection of C. trachomatis in various clinical samples. Finally, we will perform a study to compare our assay with current protocols for C. trachomatis detection, i. e.? cell culture method and direct fluorescent antibody techniques, and implement the methodology as a standard clinical assay.Awardee's statement of the potential commercial applications of the research: A reliable, clinically accepted DNA-based amplification assay for the diagnosis of C. trachomatis has yet been devised. We possess a technofogy which is capable of simultanemlslv amplifying and detecting a defined target DNA sequence. The introduction of this technology can provide clinics with a sensitive and specific, DNA-based diagnostic assay for sexually transmitted diseases.National Institute of Allergy and Infectious Diseases (NIAID)
